ML23151A428

PR-035 - 62FR40975 - License Term for Medical Use Licenses

ML23151A428
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Issue date:	07/31/1997
From:	Thompson H NRC/EDO
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PR-035, 62FR40975
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ADAMS Template: SECY-067 DOCUMENT DATE: 07/31/1997 TITLE: PR-035 - 62FR40975 - LICENSE TERM FOR MEDICAL USE LICENSES CASE

REFERENCE:

PR-035 62FR40975 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

STATUS OF RULEMAKING PROPOSED RULE: PR-035 OPEN ITEM (Y/N) N RULE NAME: LICENSE TERM FOR MEDICAL USE LICENSES PROPOSED RULE FED REG CITE: 62FR40975 PROPOSED RULE PUBLICATION DATE: 07/31/97 NUMBER OF COMMENTS: 5 ORIGINAL DATE FOR COMMENTS: 10/14/97 EXTENSION DATE: I I FINAL RULE FED. REG. CITE: 63FR31604 FINAL RULE PUBLICATION DATE: 06/10/98 NOTES ON: AMENDMENT WOULD ELIMINATE 5 YR. TERM LIMIT FOR MEDICAL USE LICENSE STATUS S & INCREASE UP TO 10 YRS. SUPPORTS NRC GOAL OF STREAMLINING LICE OF RULE: NSING PROCESS. /S/'D BY H. THOMPSON.

HISTORY OF THE RULE PART AFFECTED: PR-035 RULE TITLE: LICENSE TERM FOR MEDICAL USE LICENSES PROPOSED RULE PROPOSED RULE DATE PROPOSED RULE SECY PAPER: SRM DATE : I I SIGNED BY SECRETARY: 07/10/97 FINAL RULE FINAL RULE DATE FINAL RULE SECY PAPER: SRM DATE: I I SIGNED BY SECRETARY: 05/20/98 STAFF CONTACTS ON THE RULE CONTACT!: WILLIAM B. MCCARTHY MAIL STOP: T-8F5 PHONE: 415-7894 CONTACT2: JAYNE MCCAUSLAND MAIL STOP: T-9C24 PHONE: 415-6219

DOCKET NO. PR-035 (62FR40975)

In the Matter of LICENSE TERM FOR MEDICAL USE LICENSES DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 07/30/97 07/10/97 FEDERAL REGISTER NOTICE - PROPOSED RULE 08/06/97 08/06/97 COMMENT OF DAVID CLOSE ( 1) 09/09/97 08/26/97 COMMENT OF AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS (H. JACK BASKIN, M.D., PRESIDENT) ( 2) 09/19/97 08/27/97 COMMENT OF MAYO CLINIC (R. J. VETTER, PH.D.) ( 3) 10/14/97 10/10/97 COMMENT OF UNIVERSITY OF CINCINNATI (VICTORIA MORRIS, M.S.) ( 4) 10/14/97 10/13/97 COMMENT OF AMERICAN HOSPITAL ASSOCIATION (CHRISTINE W. MCENTEE, EXEC. V.P.) ( 5) 05/20/98 FEDERAL REGISTER NOTICE - FINAL RULE

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L' U'SNRC NUCLEAR REGULA TORY COMMISSION

°98 JUN -a A10 :32 10 CFR Part 35 RIN 3150-AF77 License Term for Medical Use Licenses AGENCY: Nuclear Regulatory Commission. OCKET 90POSED RULE 36'

(&a Fl<t/0&/ 75)

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission is amending its regulations pertaining to the medical use of byproduct material to eliminate the 5-year term limit for medical use licenses.

License terms for licenses issued under these regulations will be set by policy. Other materials licenses are issued for up to 10 years . The NRC will issue some licenses for shorter terms if warranted by the individual circumstances of license applicants. The amendment reduces the

• administrative burden of license renewals on a 5-year cycle for both NRC and licensees and supports NRC's goal of streamlining the licensing pror.ess.

M /01 lt:Jl:/8 EFFECTIVE DATE: This regulation becomes effective on (30 elays followiAg puelieetiel"I il"I the

-Federal Register).

FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland , Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington , DC 20555, telephone (301) 415-6219, e-mail JMM2@nrc.gov.

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SUPPLEMENTARY .INFORMATION:

I. Background.

II. Discussion.

Ill. Statement of Regulatory Action.

IV. Summary of Public Comments.

V. Agreement State Compatibility.

VI. Finding of No Significant Environmental Impact: Availability.

VII. Paperwork Reduction Act Statement, VIII. Regulatory Analysis.

IX. Regulatory Flexibility Certification.

X. Backfit Analysis.

I. Background In 1995, the NRC's Office of Nuclear Material Safety and Safeguards (NMSS) initiated a review to determine whether the license term for materials licenses could be lengthened so that NRC's licensing resources could be redirected to other areas of the materials program. At that time, the resources devoted to renewals constituted over 50 percent of the total resources expended for licensing. NMSS undertook this review as a part of NRC's "business process redesign" efforts.

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The license renewal process has been used as an opportunity for the Commission to review the history of the licensee's operating performance (e.g., the record on compliance with regulatory requirements) and the licensee's overall materials safety program. This review is performed to ascertain if the licensee employs up-to-date technology and practices in the protection of health, safety, and the environment, and complies with any new or amended regulations. As part of a license renewal, the licensee is asked to provide information on the current status of its program as well as any proposed changes in operations (types and quantities of authorized materials), personnel (authorized users and radiation safety officers),

• • facility, equipment, or applicable procedures. The renewal process has been perceived to benefit both the licensee and NRC because it requires both to take a comprehensive look at the licensed operation. However, in practice, comprehensive program reviews occur when proposed changes are identified and requested by licensees as license amendments rather than during the license renewal process.

License terms have been reviewed on numerous occasions since 1967. On May 12, 1967 (32 FR 7172), the Commission amended 10 CFR Part 40 to eliminate a 3-year limit on the term of source material licenses. At that time, there was no restriction on the term of byproduct licenses under 10 CFR Part 30 or special nuclear material licenses under 10 CFR Part 70. In the notice of proposed rulemaking associated with amending 10 CFR Part 40, dated December 22, 1966, NRC indicated that if the proposed amendment to eliminate the 3-year restriction were adopted, licenses would be issued for 5-year terms, except when the nature of the applicant's proposed activities indicated a need for a shorter license period. At that time, the Com~ission believed there was little justification for granting licenses under 10 CFR Parts 30, 40, and 70 for terms of less than 5 years, in view of the cumulative experience up to that 3

time and the means available to NRC to suspend, revoke, or modify such licenses if public health and safety or environment so required.

In March 1978, NMSS conducted a study (SECY-78-284, "The License Renewal Study for Parts 30, 40, and 70 Licenses") to consider changing the 5-year renewal period for Parts 30, 40, and 70 licenses. The study concluded, in part, that the NRC should continue its practice of issuing specific_ licenses for 5-year tem,s and should retain an option to write licenses for shorter tem,s, if deemed necessary, for new types of operations or if circumstances warranted.

On July 26, 1985 (50 FR 30616), NRC proposed revising 10 CFR Part 35, "Medical Use of Byproduct Material." The proposed rulemaking indicated that the Commission had selected a tern, of five years for a license. It was believed that a tern, shorter than 5 years would not benefit health and safety because past experience indicated that medical programs did not generally change significantly over that period of time. The notice also indicated that a longer tern, may occasionally result in unintentional abandonment of the license. On October 16, 1986 (51 FR 36932), NRC issued the final rule that consolidated and clarified radiation safety requirements related to the medical use of byproduct materials, and included a license term of 5 years.

On June 19, 1990 (55 FR 24948), the Commission announced that the license tern, for major operating fuel cycle licensees (i.e., licenses issued pursuant to 10 CFR Parts 40 or 70) would be increased from a 5-year term to a 10-year term at the next renewal of the affected licenses. This change enabled NRC resources to be used to improve the licensing and inspection programs. The bases for this change were that major operating fuel cycle facilities had become stable in tem,s of significant changes to their: licenses and operations and that licensees would be required to update the safety demonstration sections of their licenses every 2 years.

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On July 2, 1996, the Commission approved the NRC staffs proposal to extend the license term for uranium recovery facilities from 5 years to 1O years. Extending the license term reduces the administrative burden associated with the license renewal process for both the NRC staff and the uranium recovery licensees. Also, the extension reduces licensee fees, makes the license term for these facilities more commensurate with the level of risk, and supports NRC's goal of streamlining the licensing process. Licensees were informed of the extensions in July 1996.

On February 6, 1997 (62 FR 5656), the Commission gave notice that the license term for materials licenses issued pursuant to 10 CFR Parts 30, 40, or 70 would be increased from a 5-year term to up to a 10-year term at the next renewal of the affected licenses. However, whereas the 10-year term for other licenses was set by this policy, the term for licenses issued pursuant to 10 CFR Part 35 was established by regulation at 5 years.

On July 31, 1997 (62 FR 40975), the NRC published a proposed rule to revise 10 CFR Part 35 to eliminate the 5-year term limit in 10 CFR 35.18 for medical use licenses. The term for medical licenses could then be set by policy for up to 10 years. The NRC could issue a license for a shorter term, depending on the individual circumstances of the license applicant.

The public comment period closed on October 14, 1997. A summary of the public comments is provided in Section IV, below.

II. Discussion The change described above (i.e., increasing the license term for materials licenses issued under 10 CFR Parts 30, 40, and 70 to up to 10 years) has created an inconsistency between the license terms for medical use and nonmedical use materials licenses. NRC 5

believes that the license duration period for medical use licenses may also be extended without adverse impacts on public health and safety, such as increases in the unintentional abandonment of licensed material or decreases in the licensees' attention to licensed activities, for the following reasons:

(1) Licensees would continue to be required to adhere to the regulations and their license conditions, and to apply for license amendments for certain proposed changes to their programs; (2) No changes ln either the frequency or elements of the medical inspection program are being proposed; (3) NRC would continue to be in a position to identify, by inspection or other means, violations of its regulations or the license COr)ditions that affect public health and safety, and to take appropriate enforcement actions; (4) Cases of abandonment of NRC licenses would be identified through nonpayment of the annual licensing fees and regional NRC office follow-up; (5) The NRC staff would continue to make licensees aware of health and safety issues through the issuance of generic communications (such as information notices, generic letters, bulletins, and the NMSS Licensee Newsletter); and (6) NRC is moving to a more performance-based regulatory approach, where emphasis is placed on the licensee's execution of commitments rather than on rereview of the details of the licensee's program.

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Ill. Statement of Regulatory Action The NRC is revising Part 35 to eliminate the 5-year term limit in 10 CFR 35.18 for medical use licenses so that the term for medical use licenses will be set by policy.

IV. Discussion of Public Comments Five letters of public comment were received on the proposed rule. Comments were received from National Physics Consultants, Ltd., the American Association of Clinical Endocrinologists, the Mayo Clinic, the University of Cincinnati, and the American Hospital Association.

All commenters fully supported the proposed amendment to eliminate the reference to the 5-year term limit for medical use licenses in 10 CFR 35.18. In addition, the commenters endorsed the change in license terms for licenses issued pursuant to Part 35, to be set by policy for as many as 10 years, as are the license terms for other material licenses.

In general, commenters disparaged the license renewal process, on a 5-year frequency, as requiring a significant expenditure of time and fees ~ith minimal benefit, and supported NRC's proposal to eliminate this requirement, citing a reduction of staff time and costs for both the NRC and individual licensees with no decrease in public health and safety. Commenters recognized that the NRC may issue some licenses for shorter terms if warranted by the individual circumstances of license applicants.

One commenter stated that routine license reviews by the local Radiation Safety Committee will ensure operation of a radiation safety program that protects public health and safety.

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Another commenter indicated that because the NRC is in contact with the licensees on an ongoing basis, any changes in operations, personnel, facility, equipment, or applicable procedures are identified during the inspection and license amendment process.

One of the commenters agreed that the radiation safety programs at most medical facilities are very stable and pointed out that significant changes in the radiation safety program require license amendments.

Another commenter recommended that NRC extend the license tern, for medical use licenses from 5 years to 1O years as soon as possible to reduce the license fees and achieve

• further cost savings. This commenter expressed support for the NRC's "business process redesign" efforts to reduce both the administrative burden of license renewals and license fees.

According to the commenter, this will allow that organization's members to redirect their resources to support and implement NRC's initiative to move to a more perfomiance-based regulatory approach.

V. Compatibility for Agreement States This rulemaking will be a matter of compatibility between the NRC and the Agreement States. Compatibility Category D has been assigned to the changes in 10 CFR 35.18.

Category D means the provisions are not required for purposes of compatibility. No problem:)

have been identified regarding Agreement State compatibility implementation of this rule change.

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VI. Environmental Impact: Categorical ~xclusion The Commission has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(3)(i) for amendments to Part 35 that relate to renewals of licenses. Therefore, neither an environmental statement nor an environmental assessment has been prepared for this final regulation.

VII. Paperwork Reduction Act Statement

• This final rule reduces the burden for both medical licensees and the NRC because license terms for Part 35 licensees could be established by policy, for as many as 10 years, as is the case for other materials licensees. However, the reduced burden from less frequent license renewal will not be realized in the near future because the affected licenses are operating under a 5-year extension of current licenses granted in 1995. The impact of that one-time extension is addressed in the current supporting statement for NRC Form 313, "Application for Material License," which was approved by the Office of Management and Budget (0MB) under 0MB Clearance No. 3150-0120 and which expires on July 31, 1999. The data on reduced burden from extension of the license term for all material licenses and from other actions taken to streamline the licensing process will be included in the request for renewal of the information collection requirements on NRC Form 313 in 1999. This is appropriate because the next 0MB clearance extension will cover 1999-2002, when the medical licenses currently under the 5-year extension wi_ll expire and will be affected by this rulemaking. Send comments on any aspect of this information collection, including suggestions for further reducing the burden, to the Information and Records Management Branch (T-6F33), U.S. Nuclear 9

Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJS1@NRC.GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202 (3150-0014), Office of Management and Budget, Washington, DC 20503.

Public Protection Notification If a document used to impose an information collection does not display a currently valid OM~ control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

VIII. Regulatory Analysis Problem The current rule requirement, regarding the term of medical licenses, is codified in 10 CFR 35.18 and states that "The Commission shall issue a license for the medical use of byproduct material for a term of five years." The license term of other materials licenses, as established by Commission policy, is up to 10 years. There is an inconsistency as to duration and manner of specifying the license terms of medica*I use licenses and all other materials licenses. Based on the above, the following options were considered.

Alternative Approaches

1. Take no action: Maintain the requirement that licenses issued pursuant to Part 35 would be issued for 5 years.

This option would continue the inconsistencies between medical licenses and all other materials licenses as to the duration and specification of license terms. Terms for medical use 10

licenses are established in codified regulations, whereas the term for other materials licenses is now set by policy. Also, this option would result in disparities in the duration of the term for materials licenses. Medical use licenses would continue to be issued for 5-year terms whereas the duration of the term for other materials licenses is up to 10 years.

2. Revise 10 CFR 35.18: Revise the regulations to delete any reference to the license term for licenses issued pursuant to Part 35.

This option would result in consistency between how license terms for medical licenses and all other materials licenses are established and in the duration of these licenses.

Commission decisions regarding the duration of a materials license could therefore apply uniformly to all types of materials licenses. After final rulemaking action to revise 10 CFR 35.18, the license term for licenses issued pursuant to Part 35 would be set by the already established policy for as many as 10 years.

Value and Impact The license renewal process is resource-intensive for both the licensee and NRC. At the time of license renewal, licensees submit to NRC any changes in operations, personnel, facility, equipment, or applicable procedures. Because NRC is in contact with the licensees on an ongoing basis, many of these changes are identified during the inspection and license amendment process. Therefore, the rulemaking to remove the 5-year license term for medical use of byproduct material would not change the health and safety requirements imposed on licensees.

By removing the reference to the 5-year term in 10 CFR 35.18 and, with the Commission's February 1997 extension of the license term for as many as 10 years for all materials licenses issued pursuant to Parts 30, 40, and 70, there is a reduction in the regulatory burden for approximately 1,900 NRC licensees that use byproduct material for medical 11

procedures. Estimated savings are based on the assumption that these licensees would only be required to submit a renewal application every 1O years as opposed to every 5 years, resulting, on average, in a savings of 190 applications per year. However, offsetting these savings, medical licensees may need to submit an average of one additional amendment during the 10-year period to account for changes in operations that would have routinely been addressed when the license was renewed on a 5-year cycle. Assuming that a typical license renewal application and typical amendment involves 19 hours2.199074e-4 days <br />0.00528 hours <br />3.141534e-5 weeks <br />7.2295e-6 months <br /> and 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> of licensee professional effort, respectively, there would be a net savings per licensee of 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />. Based on an industry professional labor rate of $125 per hour, the annual industry-wide savings would approximate $356,000. Over a 30-year time frame, based on a ?-percent real discount rate, the present worth savings to industry would approximate $4.4 million.

Similarly, this rulemaking is also cost effective for the NRC because fewer resources would be required to review and process renewal applications. On average, it takes approximately 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br /> of NRC professional time to renew a medical license and 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> to review and issue a license amendment. This means a net savings to the NRC of 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> per licensee. Assuming an NRC labor rate of $125 per hour, and on average, 190 applications per year, the annual NRC savings would equal $237,000. The 30-year present worth savings to the NRC would approximate $2.9 million.

Conclusion This rulemaking, to remove the 5-year license term for medical use of byproduct material, is promulgated so the term for medical licenses will be consistent with that of other materials licenses (set by policy to be as many as 10 years). The extension will reduce the administrative burden of license renewals for both NRC and licensees and will support NRC's goal of streamlining the licensing process without any reduction in health and safety. NRC may 12

issue some licenses for shorter terms if warranted by the individual circumstances of license applicants.

Decisional Rationale Based on the desire to reduce burden whenever it is possible to do so without reducing protection of public health and safety, to maintain consistency among license terms for materials licensees, and the cost effectiveness of longer license terms, the NRG is amending 10 CFR Part 35 to eliminate the 5-year term limit for medical use licenses and allow the license term to be set by policy, as is the case for other materials licenses.

IX. Regulatory Flexlbllity Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule will not have a significant economic impact on a substantial number of small entities. By removing the reference to the 5-year license term in 10 CFR 35.18, the duration of medical use licenses will be set by policy, resulting in a reduction in the regulatory burden for NRG medical use licensees.

X. Backflt Analysis The NRG has determined that the backfit rule, 10 CFR 50.109, does not apply to this final rule and, therefore, that a backfrt analysis is not required for this final rule because the amendment does not involve any provision that would impose backfits as defined in 10 CFR 50.109(a)(1 ).

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Small Business Regulatory Enforcement Fairness Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a "major rule" and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.

List of Subjects in 10 CFR Part 35 Byproduct material, Criminal penalties, Drugs, Health facilities, Health professions, Medical devices, Nuclear materials, Occupational safety _and health, Radiation protection, Reporting and recordkeeping requirements.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C.

552 and 553, the NRC is adopting the following amendment to 10 CFR Part 35.

PART 35-- MEDICAL USE OF BYPRODUCT MATERIAL

1. The authority citation for Part 35 continues to read as follows:

AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).

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2. The introductory text of § 35.18 is revised to read as follows:

§ 35.18 License issuance.

The Commission shall issue a license for the medical use of byproduct material if:

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Dated at Rockville, Maryland, this;it> day of /V\O Al 1998.

For the Nuclear Regulatory Commission.

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15

DOCKETED USNRC "97 OCT 14 P2 :4 3 OFF!C_,..,,f.." CF.. , 1r.~ (' I ):'"'. -:~ *' ~

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U.S . Nuclear Regulatory Commission Washington, DC 20555-0001 (t 1- F fl q oc, 7 5)

Reference:

10 CFR Part 35 RIN AF77 License term for Medical Use Licenses; Proposed Rule:

Federal Register vol. 62, No. 147, July 31 , 1997 [DOCID: fr3 ljy97-26]

Dear Mr. Hoyle:

The American Hospital Association (AHA) on behalf of its 5,000 member hospitals, health systems, and other facilities is grateful for the opportunity to comment on the above-referenced Notice of Proposed Rulemaking dated July 31, 1997 regarding the proposed license term for Medical Use Licenses. The AHA supports the elimination of the five-year term limit for medical use licenses in 10 CFR 35 .18 and the change in license terms for licenses issued pursuant to part 35, set by policy up to ten years, as are the license terms for other materials licenses.

The AHA applauds this NRC initiative to reduce the administrative burden of license renewals for both NRC and licensees, and NRC's goal of streamlining the licensing process. The license renewal process is resource-intensive for both the licensee and NRC. Because the NRC is in contact with the licensees on an ongoing basis, any changes in operations, personnel, facility, equipment, or applicable procedures are identified during the inspection and license amendment process. The AHA agrees the change in license term for medical use of byproduct material would not affect public health and safety, and recognizes that the NRC may issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants. AHA actively supports this change as it reflects the NRC' s efforts to move to a more performance-based regulatory approach, where emphasis is placed on the licensee's execution of commitments rather than on re-review of the details of the licensee's program.

Furthermore, AHA recommends that the NRC extend the license term for medical use licenses from five years to ten years as soon as possible to reduce the licensee fees and achieve further cost savings.

Previous changes in license terms for material licenses have allowed NRC's licensing resources to be redirected to other areas of the materials program. The extension of license term had reduced the licensee fees for uranium recovery facilities.

Chicago, Illinois Washington, DC One North Franklin Acknowledged by card .................................. Chicago, Illinois 60606-3421 (312) 422-3000

• ,U.S. NUCLEAR REGUUffORY COMMISSION RULEMA!(INGS & ADJUDICATIONS STAFF OFFI CE 0~ THE SECRETARY c;: TH.: cmtM!SSION Postmark D,:9 I oj_,'""-'---q..,___1_ _ __

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University of Cincinnati Ra I ion Safety Office Radiation Safety Lab University of Ci ncinnati PO Box 670591 "97 OCl \4 P3 :27 Cincinnati OH 45267-0591 Phone (513) 558-41 10 Fax (513) 558-9905 OFFICE UF SEC.Fil.: fli_RY October 10, 1997 RULEMAi<H>lG~ 1,.,.ND ADJUDICA1 \L)NS ~TAFF Secretary, U.S . Nuclear Regulatory Commission ATTN: Docketing and Service Branch Washington, DC 20555-001 Re: Federal Register, July 31, 1997 (Volume 62, Number 147)

Page 40975-78, Proposed Elimination of 10 CFR 35 . 18 The University of Cincinnati supports the United States Nuclear Regulatory Commission's proposal to delete the five-year term limit for medical use licensees listed in 10 CFR 35.18.

Requiring, by regulation, all medical licensees to renew their licenses every five years does not recognize the wide variation in medical licensees.

For many individuals and institutions with unchanging medical licenses the proposed change eliminates an unnecessary, every five year, administrative burden. In addition, the proposed change also eliminates for the Nuclear Regulatory Commission the same unnecessary administrative burden. Since it is the licensees who must pay an individual to perform the licensee's portion of administrative requirements and who, through license fees , pay for the Nuclear Regulatory Commission's fulfillment of administrative requirements , elimination of a requirement which is just an administrative burden is a welcome control on the cost of having a license .

In addition to supporting the deletion of the five-year term l i mit for medical licensees , the University of Cincinnati strongly encourages the Nuclear Regulatory Commission to maintain a policy for a 10 year or greater term limit.

ave any questions , do not hesitate to call.

toria Morris, M.S., CHP Radiation Safety Officer c: R . Millard, Ph.D . , Chair Rad i ation Safety Committee D . Al brinck , Admin. Rep . Radiation Safety Committee M. Grodi, Hospital Admin . Rep . Radiation Safety Committee

• ocr *s 1-1997 Acknowledged by card ..................................

An affirmative action/equal opportunity institution

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Previously, AHA has commented on behalf of its members regarding excessive fee increases for medical use licensees even though the NRC had reported that there was a significant decrease in the number of medical licensees. Many of these licensees had discontinued their licenses in 1991 because of the fee increases. With the increase in managed care by public programs, such as Medicare and Medicaid, and health care plans that negotiate discounts, the medical use licensees-hospitals, health systems, and other facilitie~ no longer pass on fees to patients in the form of higher charges for health care services.

The AHA appreciates and supports the NRC's business process redesign efforts. A reduction in the administrative burden of license renewals and reduced licensee fees will allow AHA members to redirect their resources to support and implement the NRC' s initiative to move to a more performance-based regulatory approach.

Toward this end, AHA recommends that the agency proceed with final rule and extend the license term for medical use licenses from five years to ten years as soon as possible not only to reduce the administrative burden of license renewals, but to reduce the licensee fees and achieve further cost savings. If you have any questions regarding these comments, please do not hesitate to contact Suzanna Hoppszallem, Executive Director, Health Technology Assessment at (312) 422-3830.

Sincerely, Christine W. McEntee Executive Vice President Center for Health Care Leadership

DOCK USt Mayo Clinic Rochester, Minnesota 55905 Radiation Safety V7 SEP -. :J 1 Telephone 507 284-3332 DOCKET NUMBER p OFFICE lY PROPOSED RULE 35 RULE"

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,-j-~ ---,. 0 Re: Proposed Rule 10CFR35 : License Term for Medical Use Licenses )>C',}SJ

.,, -..... Ll Thank you for the opportunity to respond to the proposed 10CFR35 rule making regarding 10 year license renewals . Mayo Foundation supports the rule making for the following reasons :

We do not believe the extension of license renewal terms will affect public health and safety.

Routine license reviews by the local Radiation Safety Committee will ensure operation of a radiation safety program that assures public health and safety. Between renewals, small changes in licenses can be made with local Radiation Safety Committee approval; broader changes can be made with amendments when it has been determined that safety can be enhanced.

This proposed change puts medical licensees on the same renewal time frame as other types of licensees .

For the NRC and licensees, the proposed change will result in a reduction of staff time and costs with no decrease in safety.

We appreciate your consideration of this information. Should you require additional information, I can be reached at the number listed above.

Sincerely, R.J. Vetter, Ph.D.

Radiation Safety Officer cc: Radiation Safety Committee OCT S 1_117.

Acknowledged by card ...............................:.:

\J.S. NUCLEAR REGULATORY COMMlSSior.

OOCl<ETING & SERVICE SECTION OFFICE OF THE SECRETAR¥ Of THE COMMISS ON DocumentSlatistlcl Postmar1c Date _ - ...1.#J,'-=+-"'-'-- - -

Copi s Reoeived _ __,, _ _ __

Add'I ~pies Repr Special DlstrlbutiOn~ ~ ~ ~~ - - -

Z>..s

DOCKETED American Association of Clinical EndocriftBffigists "97 SEP -9 A9 :28 OFFICERS H. Jack Bukln, 11.0 ., F.A.C.E.

Ortaldo, Fl President OFFI L OF SECFff: ,1\ 8Y Htltna W. Rodbwd, 11.0, F.A.C.E.

AUL M k1f GS !,ND Rocl<vile, MD President-Elect ADJUDICA1 ICNS !:>TAFF Richard A. Dickey, 11.0., F.A.C.E.

Hickory, NC VK:e President Paul S. Jelllnger, 11.0., F.A.C.E.

Holywood, Fl DOCKET NUMBER Treasurer PROPOSED RULE PB 35'

© Rhoda H. Cobln, 11.0., F.A.C.E.

Mi<wd Park, NJ Secrelary John A. Seibel, 11.0 ., F.A.C.E. ( 1,,a Ft? 'i 097 5)

Al>uquerque, NM lmmeciale Past Presidenl August 26 , 1997 ARD OF DIRECTORS TERMS EXPIRE 1998 Nuclear Regulatory Commission Office of Nuclear Material Safety Eugene T. Davidlon, 11.D., 11.A.C.E.

Lakeland, Fl Washington, DC 20555-0001 Stanley Fold, 11.D., F.A.C.E.

Oalas, TX Cll1oe R. Hamltton Jr., 11.0., F.A.C.E.

Houston, TX John J. Janick, 11.0., F.A.C.E.

Pat ChMotte, Fl

Dear Sirs:

C. COIYld Johnaton Jr., 11.D., F.A.C.E.

lrdanapolis, IN Bill Law Jr., 11.0., F.A.C.E.

Our organization, The American Association of Clinical Knoxvile, TN Endocrinologists, strongly endorses the U.S. Nuclear Regulatory NollOII B. WIiia, 11.D., F.A.C.E.

Alla-la, GA Commission's proposal to amend 10 CFR part 35 to eliminate the TERMS EXPIRE 1999 five-year term limit for medical use licenses. We concur that the lloril G. Bartlllka, 11.D., F.A.C.E.

term should be increased to ten years to decrease the Ptiladelphia. PA administrative burden on both the NRC and individual licensees.

Bruce F. Bower, 11.D., F.A.C.E.

H.vtfofd, CT Vonk D. Coble Jr., 11.D., 11.A.C.E .

ksonvle, Fl 1111 Einhorn, 11.0 ., F.A.C.E.

• Diego, CA Houoln Gharlb, 11.D., F.A.C.E.

Rochesle,, MN ClarMa S. ~ 11.D., F.A.C.E.

Wastinglon, DC PMqUale J. Palumbo, 11.D., F.A.C.E.

Scottsdale. /12.

HJB/tg TERMS EXPIRE 2000 Donald A. e.rv,n.,, 11.D., F.A.C.E.

New Yori<, NY Samuol E. Crockett, 11.D., F.A.C.E.

Ortaldo, Fl Daniel S. Dulek, 11.D., F.A.C.E.

Cape Gira-deau, MO Sttphen F. Hodgoon, 11.D., F.A.C.E.

Rochesle,, MN Sttwn II. Pelak, 11.0 ., F.A.C.E.

Houston, TX Kriahnl II. Plmamantnl, 11.D., F.A.C.E.

Tempe, /12.

David A. Wostbrock, 11.D., F.A.C.E.

Dayton, OH SEP 1 2 1997

~clfftow1edged by card ....................... ...:n-,*

John B. Tourtllot, 11.D.

Felow-in-Training Bethesda, MD Executive Director I 000 Riverside Avenue

• Suite 205

• Jacksonville, Florida 32204 Ctvistophef' R. Seymou-, M.B.A. Phone: (904) 353-7878

• Fax: (904) 353-8185

• http://www.aace.com

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20566-0001 f_m.; Le JLA.. Lc:..(.U\.. -

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e NATIONAL PHYSl~E(i)oNSULTANTS, Ltd.

1412 Willowood Court Painesville, OH 44077-5471 US NRC "97 AUG -6 P2 :38 Facsimile (440) 350-1239 Phonemail (440) 975-2176 Telephone (440) 350-1242 (800) 397-1710 PIN 2176 OFFICf OF SECRETARY DOClff TING & SER VICE BRANLH Secretary JOCKET NUMBER p U. S. Nuclear Regulatory Commission PROPOSED RULE 3S-:

( {pt( FI< 1-oC/ 7 5)

Washington, DC 20555-0001 Re. Amending 3 5. 18

(!)

To whom it may concern; I am writing to comment on the proposed amendment to 3 5. 18 to eliminate the requirement of a five year renewal. I fully support the amendment.

I am a medical physics consultant with 24 years experience. Our firm currently consults to approximately 150 medical licensees, about half of which are NRC licensees. I agree that the radiation safety programs at most medical facilities are very stable. The license renewal process on a five year frequency is seen as a significant expenditure of time and fees with minimal benefit.

Significant changes in the radiation safety program require license amendments. The increase in risk due to this proposal is considered trivial.

We fully support the proposal. If you have any questions, feel free to contact me .

• Physicist AUG 1 1 1997

~cknowtedged by card .....................:-.;....

,. NUCLEAR REGULATORY COMMI~

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date <it11-/ q 1 Copies Received,_ _ _..__ _ __

,\dd'I Copies Reproduced __..,?.__ __

Special Distribution~

r>Pt, 'R I DS:

DOCKETED USNR, NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 *97 JUL 31 Pl2 :44 RIN : AF77 License Term for Medical Use Licenses OF~ICE 01* SECRET. RY DO vtffTIW' & S,..f:V fPE BR'*11r'H

,'-\,,._, I "**

AGENCY: Nuclear Regulatory Commission .

DOCKET NlMBER PR 35' ACTION : Proposed Rule . PROPOSED RULE..:,..:;,~--

( to!l Ff<. l/0'175)

SUMMARY

The U.S. Nuclear Regulatory Commission is proposing to amend 10 CFR Part 35 to eliminate the five-year term limit for medical use licenses in 10 CFR 35.18. License terms for

- licenses issued pursuant to Part 35 would be set, by policy up to ten years, as are the license terms for other materials licenses. The NRC would issue some licenses for shorter terms , if warranted by the individual circumstances of license applicants. The amendment would reduce the administrative burden of license renewals for both NRC and licensees , and would support NRC's goal of streamlining the licensing process.

~ I "1 / '11 '1 DATES: Submit comments by [76 sayi after p, 1blica1ti0R iA tt:ic i;edor.il Rogiiterl. Comments received after this date will be considered , if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.

- ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 . Hand-deliver coriments to: 11555 Rockville Pike, Rockville, Maryland , between 7:45 a.m. and 4:15 p.m. Federal workdays .

Copies of any comments received may be examined at the NRC Public Document Room , 2120 L Street NW (lower level), Washington , DC.

For information on submitting comments electronically, see the discussion under Electronic Access in the Supplementary Information section .

FOR FURTHER INFORMATION CONTACT: William B. McCarthy, Office of Nuclear Material Safety and Safeguards, U. S. Nuclear Regulatory Commission, Washington , DC 20555-0001 ,

telephone (301) 415-7894; e-mail WBM@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background In 1995, the NRC Office of Nuclear Material Safety and Safeguards (NMSS) initiated a review to determine whether the license term for material licenses could be increased so that NRC's licensing resources could be redirected to other areas of the materials program. The resources devoted to renewals constituted over 50 percent of tbe total resources expended for licensing. NMSS undertook this review as a part.of NRC's business process redesign efforts.

The license renewal process has been used as an opportunity for the Commission to review: (1) the history of the licensee's operating performance (e.g., the record on compliance with regulatory requirements); and (2) the licensee's program. This review is performed to _ -

ascertain if the licensee employs up-to-date technol_ogy and practices in the protection of health, safety, and the environment, and complies with any new or amended regulations. As part of a license renewal, the licensee is asked to provide information on the current status of its program as well as any proposed changes in operations (types and quantities of authorized materials}, personnel (authorized users and radiation safety officers), facflity, equipment, or applicable procedures. The renewal process has been perc;t;1ved to benefit both the licensee and NRC because it requires both to take a comprehensive look at the licensed operation.

However, in practice, most of the proposed changes are identified and requested by licensees as amendments rather than during the li~nse renewal process.

License terms hav~ been reviewed on numerous occasions since 1967. On U..' '

May 12, 1967 (32 FR 7172), the Commission amended 10 CFR Part 40 to eliminate a three-year limit Or) the term of source material licenses. At that time, there was no restriction on the term of byproduct licenses under 10 CFR Part 30 or special nuclear mate.rial licenses, under 10 CFR Part 70. In the notice of proposed rulemaking associated with this rule, dated December 22, 1966, NRC indicated that if the proposed amendment to eliminate the three-year restriction were adopted, licenses would be issued for five-year terms, except when the nature of the applicant's proposed activities indicated a need for a shorter license period. At that time, the Commission believed there was little justification for granting licenses under 10 CFR Parts 30, 40, and 70 for terms of less than five years, in view of the cumulative experience up to tha~

2

time and the means available to NRC to suspend, revoke, or modify such licenses if public health and safety or environment so required. Licenses have been issued for five-year terms since 1967.

In March 1978, NMSS conducted a study (SECY-78-284, "The License Renewal Study for Parts 30, 40 and 70 Licenses") to consider changing the five-year renewal period for Parts 30, 40, and 70 licenses. The study concluded, in part, that the NRC should continue its practice of is~ui,ng specific licenses for five-year terms and should retain an option to 'write licenses for shorter terms, if deemed necessary for new types of operations, or if circumstances warranted.

On July 26, 1985 (50 FR 30616), NRC proposed revising 1O CF~ Part 35, "Medical Use of Byproduct Material." ~~ proposed rulemaking indicated thatrthe Commission had selected a term of five years for a license. It was believed that a term shorter than five years would not benefit health and safety because past experience indicated that medical programs did not generally change significantly over that period of time. The notice also indicated that a longer term may occasionally result in unintentional abandonment of the license. On October 16, 1986 (51 FR 36932), NRC issued the final rule that consolidated and clarified radiation safety j

requirements related to the medical use of byproduct materials, and included a license term of five years.

On June 19, 1990 (55 FR 24948), the* Commission announced that the license term for major operating fuel cycle licensees (i.e., licenses issued pursuant to 10 CFR Parts 40 or 70) would be increased from a five-year term to a ten-year term at the next renewal (?f the affected licenses., This change enabled NRC resources to be used to improve the licensing and inspection programs. The bases for this change were that major operating fuel cycle facilities had become stable in term~-of significant changes to their licenses and operations, and that _,~,

. ~*

licensees would be required to update the safety demonstration sections of their licenses every two years.

On July 2, 1996, the Cqr,mission approved the NRC staffs proposal to extend the license term for uranium recovery facilities from five years to ten years. Extending the license terms reduces the administrative burden associated with the license renewal process for both the NRC staff and the uranium recovery licensees. AlsQ.Jhe extension reduces the licensee fees, brings the license term for these facilities more commensurate with the level of risk, and supports NRC's goal of streamlining the licensing process. Licensees were informed of the extensions in July 1996.

3

/

On February 6, 1997 (62 FR 5656), the Commission gave notice of the policy that the license term for material licenses issued pursuant to 10 CFR Parts 30, 40, or 70 would be increased from a five-year term to up to a ten-year term at the next renewal of the affected licenses. The term for licenses issued pursuant to 10 CFR Part 35 is established by regulation at five years. The ten-year term for other licenses has been set by policy. Part 35 license r

terms would be set by this policy after the final rule is effective that removes the reference to a five-year license term from 10 CFR 35.18. The NRC may issue a license for a shorter term, depending on the individual circumstances of the license applicant.

11. Discussion The change in policy under which the license term for materials licenses is up to ten years, has created an inconsistency between .the license terms for medical use and non-medical use mate'rials licenses. NRC believes that the license duration period may also be extended without adverse impacts on public health and safety, such as increases in the unintentional abandonment of licensed material, or decreases in the licensees' attention to licensed activities, for the following reasons:

(1) Licensees would continue to be required to adhere to the regulations and their license conditions, and)o apply for license amendments for certain proposed changes to their programs;

/

(2) No changes in either the frequency or elements of the medical inspection program are being proposed; (3) NRC would continue to be in the position to identify, by inspection or other means, --

violations that affect public health and safety, and to take appropriate enforcement actions; (4) Cases of abandonment of NRC licenses would be identified through nonpayment of the annual licensing fees and regional follow-up; (5) The staff would continue to make licensees aware of health and safety issues through the issuance of generic communications (such as information notices, generic letters, bulletins, and the NMSS Licensee Newsletter}; and (6) NRC efforts are moving to a more performance-based regulatory approach, where emphasis Js placed on the licensee's execution of commitments rather than on re-review of the details of the licensee's program.

4

Ill. Proposed Regulatory Action The NRC is proposing to revise Part 35 to eliminate the five-year term limit in 10 CFR 35.18 for medical use licenses, so that the term for medical licenses can be set by policy for up to ten years.

IV. Compatibility for Agreement States No problems have been identified regarding Agreement State implementation of this rule

_change. Section 35.18 is a Division 3 requirement. _For purposes of NRC and Agreement State r

compatibility requirerr. :..its, Division 3 rules apply !o a number of the provisions in NRC regulations that would be appropri~te for Agreement States to adopt, but they do not require any degree of uniformity between NRC and State rules. Such rules are strictly matters for the regulatory agency and the regulatory community within its jurisdiction. NRC encourages states to adopt the regulatory approach taken by NRC in such rules, but states are not required to do so. Under the new Commission Policy Statement on Agreement State Compatibility, Division 3 rules will be classified as compatibility category D with the same description as Division 3.

V. Electronic Access Comments may be submitted electronically, in either ASCII text or WordPerfect format,

- by calling the NRC Electronic Bulletin Board on FedWorld. The bulletin board may be accessed using a personal computer, a modem, and one of the commonly available communications software packages, or directly via Internet. Background documents on the rulemaking are also available, as practical, for downloading and viewing on the bulletin board.

If using a personal computer and modem, the NRC rulemaking subsystem on FedWorld

'can be accessed directly by dialing the toll-free number (800) 303-9672. Communication

• software parameters should be set as follows: parity to none, data bits to 8, and stop bits to 1 (N,8, 1). Using ANSI or VT-100 terminal emulation, the NRC rulemaking subsystem can then be accessed by selecting the "Rules Menun option from the "NRC Main Menu.n Users will find the "FedWorld Online User's Guides* particularly helpful. Many NRC subsystems and data bases also have a "Help/Information Centet option that is tailored to the particular subsystem.

5

The NRC subsystem on FedWorld can be accessed by a direct dial phone number for the main FedWorld BBS (703) 321-3339, or by using Telnet via Internet: fedworld.gov. If using (703) 321-3339 to contact FedWorld, the NRC subsystem will be accessed from the main FedWorld menu by selecting the "Regulatory, Government Administration and State Systems,"

then selecting "Regulatory Information Mall." At that point, a menu will be displayed that has an option "US Nuclear Regulatory Commission" that will take you to the NRC Online main menu.

The NRC Online area also can be accessed directly by typing "/go nrc" at a FedWorld command line. If you access NRC from FedWorld's main menu, you may return to FedWorld by selecting the "Return to FedWorld" option from the NRC Online main menu. However, if you access NRC at FedWorld by using NRC's toll-free number, you will have full access to all NRC systems, but you will not have access to the main FedWorld systems.

• If you contact FedWorld using Telnet, you will see the NRC area and menus, including the Rules menu. Although you will be able to download documents and leave messages, you will not be able to write comments or upload files (comments). If you contact FedWorld using FTP, all files can be accessed and downloaded but uploads are not allowed; all you will see is a list of files without de,scriptions (normal Gopher look). An index file listing all files within a subdirectory, with description, is available. There is a 15-minute time limit for FTP access.

Although FedWorld also can be accessed through the World Wide Web, like FTP, that mode only provides access for downloading files and does nut display NRC Rules menu You may also access the NRC's interactive rulemaking web site through the NRC home page (http://www.nrc.gov): This site provides the same access as the FedWorld bulletin board, including the facility to upload comments as files (any format), if your web browser supports that function.

For more information on the NRC bulletin boards call Mr. Arthur Davis. Systems Integration and Development Branch, NRC, Washington DC 20555-0001, telephone (301) 415-5780; e-mail AXD@nrc.gov. For information about the interactive rulemaking site, contact Ms.

• Carol Gallagher (301) 415-6215; e-mail CAG@nrc.gov. ~

6

VI. Finding of No Significant Environmental Impact: Availability No Environmental Assessment will be needed because the rulemaking is covered by the categorical exclusion in 10 CFR 51.22 (c)(3)(i) for amendments to Part 35 that relate to renewals of licenses.

VI I. Paperwork Reduction Act Statement This proposed rule will reduce the burden for both medical licensees and NRC, because terms could be established py policy, for up to ten years, .as is the case fo~ other material licensees. However, the reduced burden from less frequent license renewal will not be realized in the near future because the affected licenses are operating under a five-year extension of their current licenses which were granted in 1995. The impact of that one-time extension is addressed rn the current supporting statement for NRC Form 313, "Application for Material License" which was approved by the Office of Management and Budget (0MB) under 0MB clearance No. 3150-0120, and expires on July 31, 1999. The data on the reduced burden from extension of the license term for all material licenses, as well as from other actions taken to streamline the licensing process, will be included in the request for renewal of the information collection requirements on NRC Form 313, in 1999. This is appropriate because the next 0MB clearance extension will cover 1999 - 2002, during which time the medical licenses currently under the five year extension will expire and be affected by this rulemaking.

Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, an information collection unless it displays a currently valid 0MB control number.

7

VIII. Regulatory Analysis Problem:

The current rule requirement, regarding the term of medical licenses, is codified in Section 35. 18 and states that, "The Commission shall issue a license for the medical use of byproduct material for a term of five years." The License term of other materials licenses, as established by Commission policy, is up to ten years. There is thus an inconsistency as to duration and manner of determination of the license term of medical use licenses and all other matenals licenses. Based on the above, the following options were considered.

Alternative Approaches:

1. Take no action: Maintain the requirement that licenses issued pursuant to Part 35 would be issued for five years.

This option would continue the inconsistency between how license terms for medical licenses, and all other materials licenses, are established. Terms for medical use licenses are established in codified regulations, whereas the term for other materials licenses are set by policy. Also, this option would result in disparities in the duration of the term for material licenses, because medical use licenses would continue to be issued for five-year terms whereas the duration of the term for other materials licenses would be up to ten years.

2. Revise 10 CFR 35.18: Revise the regulations to delete any reference to the license term for licenses issued pursuant to Part 35.

This option would result in consistency between how license terms for medical licenses and all other material licenses are established and in the duration of such licenses.

Commission decisions regarding the duration of a materials license could therefore apply uniformly to 'all types of material licenses. After final rulemaking action to revise 10 CFR 35.18, the license term for licenses issued pursuant to Part 35 would be set by already established policy for up to ten years.

Value and Impact:

The license renewal process is resource-intensive for both the licens.ee and NRC. At the time of license renewal, licensees submit to NRC any changes in operations, personnel, facility, equipment, or applicable procedures. Because NRC is in contact with the licensees on 8

an ongoing basis, many of these changes are identified during the inspection and license amendment process. Therefore, the rulemaking to remove the five-year license tenn for medical use of byproduct material would not change the health and safety requirements imposed on licensees.

If the reference to the five-year tenn in 10 CFR 35. 18 is removed, and with the Commission's approval (February 1997) given to extend the license tenn up to ten years for all material licenses issued pursuant to Parts 30, 40, and 70, there would be a reduction in the regulatory burden for approximately 2,000 NRC licensees that use byproduct material for medical procedures. Estimated savings are based on the assumption that these licensees I

would only be required to submit a renewal application every ten years as opposed to every five years, resulting, on average, in a.savings of 200 applications per year. However, countervailing these savings, medical licensees may need to submif an average of one additional amendment during the ten year period to account for changes in operations that would have routinely been addressed when the license was renewed on a five year cycle. Assuming that a t)'pical license renewal application and typical amendment involves ten hours and two hours of licensee professional effort, respectively, there would be a net savings per licensee of eight hours.

Based on an industry professional labor rate of $70 per hour, the annual industry-wide savings would approximate $112,000. Over a 30-year time frame, based on a 7 percent real discount rate, the present worth savings to industry would approximate $1.4 million.

1 Similarly, this rulemaking would also be cost effective for the NRC because fewer resources would be required to review and process renewal applications. On average, it takes approximately 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br /> of NRC professional time to renew a medical license and four hours to review an amendment. This translates to a net savings to the NRC of 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> per license.

Assuming an NRC labor rate of $70 per hour, and on average, 200 application per year, the annual NRC savings would equal $140,000. The 30 year present worth savings to the NRC would approximate $1.7 million.

==

Conclusion:==

This rulemaking, to remove the five-year license tenn for medical use of byproduct material, is proposed so the tenn for medical licenses will be consistent with that of other materials licenses (set by policy to be up to 10 years). The extension will reduce the 9

admin_istrative burden of license renewals for both NRC and the licensee and will support NRC's goal of streamlining the licensing process without any reduction in health and safety. NRC may

_ issue some licenses for shorter terms, if warranted by the individual circumstances-of license applicants.

Decisional Rationale:

Based on the consistency which is created between license terms for medical licenses and all other material licenses by the rulemaking, and the cost effectiveness of a license term of up to ten years, the NRC is proposing to amend 10 CFR Part 35 to eliminate the five-year term limit for medical use licenses and allow the license term to be set by the established policv for up to ten years.

IX. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule, if adopted, will not have a significant impact on a substantial number of small entities. If any small entity subject to this regulation determines that, because of its size, it is likely to bear a disproportionate adverse eco'nomic impact, the entity should notify the Commission of this in a comment that indicates the following:

(a) The licensee's size and how the proposed regulaiion would result in a significant economic burden upon the license compared to the economic burden on a larger licen~~e; (b) How the proposed regulation could be modified to take into account the licen,see's I

differing needs and capabilities; (c) The benefits th.:it would accrue, or the detriments that would be avoided, if the proposed rule were modified as suggested by the licensee; (d) How the proposed regulation, as modified, would more closely equalize the impact of NRC regulations or create more equal access to the benefits of Federal programs, as opposed to providing special advantages to any one individual or group; and (e) How the proposed regulation, as modified, would still adequately protect public health and safety.

10 '

X. Backfrt Analysis The NRC has determined that the backfrt rule, 10 CFR 50.109, does not apply to this rule, and therefore a backfit analysis is not required because the amendment does not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1 ).

XI.. List of Subjects 10 CFR Part 35 Byproduct Material, Criminal penalties, Drugs, Health facilities, Health professions, Nuclear materials, Occupational safety and health, Radiation protection, Reporting and record requirements.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act *of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C.

552 and 553; the NRC is adopting the following amendments to 10 CFR Part 35.

PART 35-MEDICAL USE OF BYPRODUCT MATERIAL

1. The authority citation for Part 35 continues to read as follows:

Authority: Secs. 81, 161, 182, 183, 68 Stat. 935,948,953,954, as amended (42 U.S.C.

2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242; as amended (42 U.S.C. 5841).

2. The introductory text of section 35.18 is revised to read as follows:

§ 35, 18 License issuance The Commission sh~II issue a license for the medical use of byproduct material if:

Dated at Rockville, Maryland, this lOtt\jay of July, 1997.

For the Nuclear Regulatory.Commission Executiv perations 11